The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain

NCT07546084 | Recruiting

• 1 other identifier: 03032001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to investigate the effects of an attention shift-based rehabilitation program on clinical outcomes in individuals with rotator cuff-related shoulder pain (RCRSP). The study will evaluate the effects of an attention shift approach, in which motor tasks targeting regions outside the shoulder are performed concurrently with standard shoulder exercises, on pain, functional status, and pain catastrophizing. These results will be compared with those of a standard shoulder rehabilitation program. The main questions this study aims to answer are: Is there a difference in pain levels between individuals with RCRSP who participate in an attention shift-based rehabilitation program and those who participate in a standard exercise program? Is there a difference between these two rehabilitation approaches in terms of shoulder function and pain catastrophizing? Participants will: Be randomly assigned to either an attention shift-based rehabilitation group or a standard shoulder rehabilitation group Participate in supervised exercise sessions twice per week for 6 weeks Attend sessions lasting approximately 60-75 minutes Undergo clinical assessments at baseline and at week 6

Conditions

Rotator Cuff Related Shoulder Pain; Subacromial Pain Syndrome; Shoulder Bursitis; Shoulder Tendinopathy; Rotator Cuff Tears of the Shoulder

Keywords

Rotator cuff; Shoulder pain; attention shift

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  NPRS will be used to evaluate pain levels. The scale consists of a numeric rating system ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate the intensity of their shoulder pain.

  At baseline, at week 6, and at week 12

Secondary Outcomes (2)

• The Western Ontario Rotator Cuff Index (WORC)

  At baseline, at week 6, and at week 12.

• Pain Catastrophizing Scale (PCS)

  At baseline, at week 6, and at week 12

Study Arms (2)

Attention Shift-Based Rehabilitation Group

EXPERIMENTAL

Participants in this group will receive a supervised shoulder rehabilitation program combined with motor tasks targeting regions outside the shoulder. These additional tasks are designed to shift attention away from the painful shoulder region. Exercises will be performed twice per week for 6 weeks, with each session lasting approximately 60-75 minutes. All participants will also receive standardized patient education.

Other: Patient Education; Other: Attention Shift-Based Exercise Therapy

Standard Exercise Group

ACTIVE COMPARATOR

Participants in this group will receive a standardized shoulder rehabilitation program consisting of conventional therapeutic exercises. No attention-shifting or additional motor tasks will be included. The program will be administered twice per week for 6 weeks, with each session lasting approximately 60-75 minutes. All participants will also receive standardized patient education.

Other: Patient Education; Other: Standard Exercise Therapy

Interventions

Patient Education OTHER

Participants will receive patient education on basic muscle biomechanics, causes of rotator cuff-related shoulder pain, pain management strategies, activity modification, and proper sleeping positions.

Attention Shift-Based Rehabilitation Group; Standard Exercise Group

Attention Shift-Based Exercise Therapy OTHER

Participants will be enrolled in a structured, supervised shoulder rehabilitation program consisting of exercises recommended in the literature. The program will include a three-phase protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. In addition to the standard shoulder exercise program, participants will perform concurrent motor tasks targeting regions outside the shoulder. These tasks are designed to shift attention away from the painful shoulder region by engaging other body segments (e.g., lower limb or contralateral limb movements performed simultaneously with shoulder exercises). The intervention will be delivered under the supervision of a physiotherapist twice per week over a 6-week period.

Attention Shift-Based Rehabilitation Group

Standard Exercise Therapy OTHER

Participants will be enrolled in a structured, supervised standard shoulder rehabilitation program consisting of exercises recommended in the literature. The program will include a three-phase protocol comprising range of motion exercises, stretching exercises, and strengthening exercises. The intervention will focus exclusively on the affected shoulder and will not include any additional cognitive or motor dual-task components or attention-shifting strategies. All exercises will be performed under the supervision of a physiotherapist twice per week over a 6-week period.

Standard Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having symptoms persisting for at least 3 months
• Experiencing pain intensity of at least 3 on the Numeric Pain Rating Scale (NPRS) during activity
• Presence of a painful arc during shoulder flexion or abduction
• Positive Neer test or Hawkins-Kennedy test
• Pain provoked by resisted external rotation/abduction of the humerus, or a positive Jobe (Empty Can) test
• Having a clinical diagnosis of subacromial pain syndrome, rotator cuff tendinopathy, subacromial bursitis, or symptomatic partial/full-thickness rotator cuff tear
• Being able to understand and complete questionnaires in Turkish

You may not qualify if:

• Presence of adhesive capsulitis (≥30% limitation in passive range of motion)
• Advanced osteoarthritis of the shoulder
• History of fracture or dislocation affecting the shoulder region
• Advanced acromioclavicular joint pathology
• Massive rotator cuff tear (positive lag signs)
• Previous shoulder surgery
• Presence of neurological disorders
• Diagnosis of rheumatoid arthritis
• History of cancer
• Symptomatic cervical spine pathology
• Corticosteroid injection to the shoulder within the past 6 weeks
• Cognitive impairments that may interfere with the ability to perform clinical tasks or execute attention shift-based exercises

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Rezzan Atay, Bachelor's degree

CONTACT

90+ 505 485 75 49; rezzan.atay@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two parallel groups: an attention shift-based rehabilitation group or a standard rehabilitation group. Both groups will receive supervised exercise interventions over a 6-week period, and outcomes will be compared between groups

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)